August 28, 2009 — For patients with migraines who are difficult to manage with standard protocols, there might be a new option that could prove to have a therapeutic, as well as a cosmetic, effect. Results from a placebo-controlled surgical trial appear in the August issue of Plastic and Reconstructive Surgery.

Investigators, led by Bahman Guyuron, MD, from Case Western Reserve University in Cleveland, Ohio, report response rates of at least a 50% reduction in intensity, frequency, and duration of migraines. Response rates reportedly jump to as much as 90% when trigger sites are surgically deactivated.

The numbers, though compelling, have furrowed the brow of more than one neurologist. "Too good to be true?" Dr. Guyuron told Medscape Neurology he has heard many variations of this question. "A certain degree of skepticism is healthy," he said, "but there's no question in my mind we are seeing results, and patients are experiencing an enduring positive response."

Jeffrey Janis, MD, from the University of Texas Southwestern Medical Center in Dallas, said he agrees. "I completely understand the concerns; this has been considered an experimental approach. This is certainly not the standard of care, but it may be an alternative for patients experiencing difficulty with traditional therapies."

Experimental Approach

In an accompanying discussion in the journal, Dr. Janis noted that "this article, simply put, represents the definitive proof that surgical decompression of peripheral trigger points in the treatment of migraine headaches is a valid concept."

Compared with the control group, the forehead-lift group demonstrated statistically significant improvements in all validated migraine headache measurements at 1 year. These improvements were not dependent on trigger site.

Reductions in Migraine at 1 Year

Outcome

Forehead Lift (%)

Sham Surgery (%)

P Value

50% reduction in migraines

83.7

57.7

No migraines after surgery

57.1

3.8

?

Investigators performed all procedures in an ambulatory center with an average surgery time of less than 1 hour. Patients were permitted to resume ordinary activities in 1 week and heavy exercise in 3 weeks.

The most common surgical complication was a slight hollowing of the temple in the group with temporal migraine.

Adverse Events

Events

Group

Percentage

Numbness at 1 year

Temporal

5

Hollowing

Temporal

53

Intense itching

Frontal

11

Uneven brow movement

Frontal

5

Temporary hair loss or thinning

Temporal

5

Residual corrugator supercilii muscle function

Frontal

5

Neck stiffness at 1 year

Occipital

9

Dr. Guyuron and his team propose a possible mechanism to explain the benefit of surgery. They suggest that peripheral activation of the trigeminal nerve with subsequent peripheral and central sensitization could be at play.

Although the results appear promising on some levels, there were problems with the study. For example, 1 of the 26 patients undergoing sham surgery actually had complete elimination of migraines at 1 year.

Researchers suggest this may be attributed to the surgical undermining of flaps, neurapraxias from nerve manipulation, or the placebo effect. But the beneficial effect did persist at 1 year.

Another 8 of the 49 patients who underwent the forehead lift had no change in migraines after treatment. The authors point out that only 1 trigger point was addressed, and this could have neglected others prompting migraine.

Dr. Janis says he's not concerned about these numbers. "The fact is that there exists a small subpopulation of nonresponders in all available clinical studies on this subject."

Dr. Guyuron said his group will present new 5-year results in October. He said the findings are promising.

This study was paid for by the Migraine Foundation, the Plastic Surgery Education Fund, and the Prentiss Foundation. Coauthor Dr. Deborah Reed, from Case Western Reserve University in Cleveland, Ohio, reports that she is a consultant for Allergan and GlaxoSmithKline. Coauthor Dr. Jennifer Kriegler, also from Case Western Reserve University, reports that she is a consultant for Pfizer, GlaxoSmithKline, Merck, and Endo.